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Completed

NCT Number: NCT05818462

Bladder and Bone Effects of Pelvic Radiation Therapy in Childhood Cancer Survivors

The aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization.

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Key information

Conditions

Cancer Childhood Cancer Neoplasms

Age range

2 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Colorado Research Center

Aurora, Colorado, 80217, United States

About this study

The aim of this study is to measure and evaluate the effects of pelvic external beam radiation therapy (EBRT) on lower urinary tract (LUT) function and bone mineralization. The overarching hypothesis is that patients who received EBRT to the pelvis will have an increased rate of LUT dysfunction and osteoporosis even when controlled for chemotherapeutic exposures, using patients with similar chemotherapy regimens as controls. Between these two groups, the team expect to observe significant differences in both patient-reported outcomes and direct measures of LUT function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of any age who were treated were diagnosed in 2007 or later and received chemotherapy for solid tumor malignancy, with completion of therapy (whether chemotherapy or radiation) at least one year prior to study enrollment.

Exclusion criteria

  • Patients with known dysfunctional voiding prior to cancer treatment.
  • Patients with tumor resection of bladder, prostate or gynecologic organs will be excluded.

Treatment and study plan

Uroflow testing

Diagnostic Test

Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.

Bladder Scan

Diagnostic Test

Bladder scan measures ultrasonic reflections within the patient's body to differentiate the urinary bladder from the surrounding tissue. In this case, it is used to detect the volume of urine in the bladder.

Dysfunctional Voiding Scoring System Survey

Other

The Dysfunctional Voiding Symptom Score to provide accurate and objective numerical, grading of voiding behaviors of children.

DEXA Scan of pelvis and sacral spine

Diagnostic Test

DEXA (dual x-ray absorptiometry) scans measure bone density (thickness and strength of bones) by passing a high and low energy x-ray beam (a form of ionizing radiation) through the body, usually in the hip and the spine.

Urine tests for specific biomarkers

Diagnostic Test

Urine tests for specific biomarkers (ATP, NGF, BNDF and urine proteomic screening).

Primary outcomes

  1. Uroflow and Bladder Scan Results

    Time frame: 1.5 years

    aggregate measured by voiding time (seconds, s), total voided volume (mL), average uroflow rate (mL/s), maximum uroflow rate (mL/s), uroflow pattern or curve (bell-shaped, tower-shaped, staccato, interrupted or plateau), and post void residual (mL)

Secondary outcomes

  1. DVSS Scores

    Time frame: 1.5 years

    • Total DVSS survey scores to determine patient-reported urinary symptom. Gender-specific DVSS total score thresholds: males ≥9, females ≥6. Minimum DVSS score is 0 points. Maximum DVSS score is 30 points.

  2. Number of Patients with Osteoporosis

    Time frame: 1.5 years

    • Rates of osteopenia and osteoporosis, as determined by bone density Z-score using DEXA scan of pelvis and sacral spine. Osteopenia is defined as a z-score between - 1 to -2.5, while osteoporosis is defined as a z-score below -2.5

  3. DEXA Scan Results

    Time frame: 1.5 years

    • Average pelvic and sacral spine bone mineral density Z-scores, as determined by a DEXA scan of pelvis and sacral spine.

Other outcomes

  1. Biomarker - ATP

    Time frame: 1.5 years

    Measure biomarker ATP in order to determine urinary biomarkers for investigation into radiation-induced LUTD.

  2. Biomarker - NGF

    Time frame: 1.5 years

    Measure biomarker NGF in order to determine urinary biomarkers for investigation into radiation-induced LUTD.

  3. Biomarker - BNDF

    Time frame: 1.5 years

    Measure biomarker BNDF in order to determine urinary biomarkers for investigation into radiation-induced LUTD.

  4. Biomarker - urine proteomic screening results

    Time frame: 1.5 years

    Measure urinary excreted proteins and peptides via urine proteomic screening in order to determine urinary biomarkers for investigation into radiation-induced LUTD.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Effect of Pelvic Radiation Therapy on the Urinary and Musculoskeletal Systems of Survivors of Childhood Cancer

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2023
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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